A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Adagen Online, Description, Chemistry, Ingredients - Pegademase Bovine
Adagen Online, Description, Chemistry, Ingredients - Pegademase Bovine
DESCRIPTION
ADAGEN® (pegademase bovine) Injection is a modified enzyme used for
enzyme replacement therapy for the treatment of severe combined immunodeficiency
disease (SCID) associated with a deficiency of adenosine deaminase.
ADAGEN® (pegademase bovine) Injection is supplied in an isotonic, pyrogen
free, sterile solution, pH 7.2-7.4, for intramuscular injection only. The solution
is clear and colorless. It is supplied in 1.5 mL single-dose vials.
The chemical name for ADAGEN® (pegademase bovine) Injection is (monomethoxypolyethylene
glycol succinimidyl) 11 - 17 -adenosine
deaminase. It is a conjugate of numerous strands of monomethoxypolyethylene
glycol (PEG), molecular weight 5,000, covalently attached to the enzyme adenosine
deaminase (ADA). ADA (adenosine deaminase EC 3.5.4.4) used in the manufacture
of ADAGEN® (pegademase bovine) Injection is derived from bovine intestine.
x = 114 oxyethylene groups per PEG strand.
y = 11-17 primary amino groups of lysine onto which succinyl PEG is attached.
Each milliliter of ADAGEN® (pegademase bovine) Injection contains:
|
Pegademase bovine 250
units *
|
|
Monobasic sodium phosphate, USP 1.20
mg
|
|
Dibasic sodium phosphate, USP 5.58
mg
|
|
Sodium Chloride, USP 8.50
mg
|
|
Water for Injection, USP
q.s. to 1.0 mL
|
|
*One unit of activity is defined as the amount of ADA
that converts 1 µM of adenosine to inosine per minute at 25°C and pH
7.3.
|
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